Regulatory submissions built for precision medicine and diagnostics

Strategy and execution for the therapeutics, companion diagnostics and biomarker-driven programmes at the centre of precision medicine — coordinated across FDA, EMA, MHRA and EU IVDR requirements.

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WORKING METHOD●

01Strategy

02Co-develop

03Submit

FocusAligned Rx/Dx approval

WHAT WE COVER

Every decision that carries programme risk

Precision medicine regulatory strategy

Biomarker and patient-selection evidence translated into a defensible regulatory position, built around how a health authority will actually review it.

Companion diagnostic (CDx) co-development

Coordinated therapeutic and diagnostic development plans so the CDx and the drug or biologic move through analytical validation, clinical evidence and review in step.

IVD, IVDR & FDA device submissions

Submission-ready packages spanning IDE, 510(k), De Novo and PMA in the US, and EU IVDR technical documentation and Annex XIV filings for Class C companion diagnostics.

Global submission execution

Filing strategy, health-authority interaction and lifecycle management across FDA, EMA, MHRA and other regional bodies, kept in step with the paired therapeutic submission.

WAYS TO ENGAGE

A fixed sprint or embedded leadership

SCOPE-BASED

CDx Pathway Assessment

Determine the fastest defensible regulatory route for a diagnostic tied to a therapeutic label claim.

MONTHLY

Rx/Dx Programme Leadership

Ongoing regulatory ownership across the paired therapeutic and diagnostic workstreams.

PER FILING

Submission Preparation & QC

Build and quality-check IDE, PMA, 510(k), De Novo or IVDR technical files before they are filed.

GO DEEPER

Where submissions connects to operations

REGULATORY

Back to the Regulatory overview

Submission strategy, health-authority meetings and fractional regulatory leadership.

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REGULATORY OPERATIONS

Applications, SOPs & document authoring

The application planning, SOP governance and CTD authoring work behind every submission.

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START WITH THE CONSTRAINT

What is slowing your programme — or which capability is your team missing?

Tell us the decision, deliverable or role you are working through. We will help identify the most useful next step.

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